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Validation Manager
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- The Validation Manager is responsible for managing Validation personnel at Melrose Park facility.
- Manage a team of Principal, Senior and entry-level Validation Engineers whose responsibility is to perform qualification, re-qualification, and periodic review of equipment, processes, and utilities.
- Provide technical expertise and oversight on various technical documents (MBR's, New Product Validation Reports, MCR's, etc
- Ensures compliance with FDA and other relevant regulatory requirements and standards Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
- Responsible for the overall completion of validation studies including reviewing, scheduling, and overseeing the process (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and review/ approve final report preparation.
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